[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07076264":3,"trial-entities:NCT07076264":111,"trial-summary:NCT07076264":115},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":39,"secondary_outcomes":44,"sex":54,"minimum_age":55,"maximum_age":56,"healthy_volunteers":15,"eligibility_criteria":57,"std_ages":74,"locations":76,"central_contacts":95,"overall_officials":100,"references":101,"see_also_links":110},"NCT07076264","STUDY20250101","Water Competency Intervention in Autism","Water Competency Intervention for Children on the Autism Spectrum: The AquOTic Hybrid Effectiveness Implementation Trial","RECRUITING","2029-04","2025-11","2025-12-04","2025-09-19","Ohio State University","OTHER",false,"AquOTic is an evidence-based, occupational therapy-led intervention designed to enhance water competency and swim safety skills in children on the autism spectrum. The 10-week program consists of weekly 60-minute group sessions, each including six children paired in a 1:1 ratio with an interventionist. Sessions follow a structured routine involving six rotating stations, targeting various swim and safety skills, with the flexibility for individualized support by the interventionist.\n\nOverall, this study has 3 major aims. The first aim evaluates the effectiveness of the AquOTic intervention in improving water competency and swim skills, while comparing outcomes between two implementation models: professional student interventionists (occupational and physical therapy students) and trained community-based interventionists. A total of 108 autistic children will be enrolled and randomly assigned to one of three groups: (1) AquOTic with professional student interventionists, (2) AquOTic with community interventionists, or (3) a control group receiving no AquOTic intervention. The second aim explores the mediators and moderators of the intervention outcomes to assess fidelity and efficacy. The third aim identifies the cost and resources associated with AquOTic. A cost analysis will be conducted to evaluate the resources required for implementation and to inform the development of a scalable, cost-effective drowning prevention strategy for autistic populations.",null,[19],"Autism Spectrum Disorders",[21,22,23,24,25],"Swim Safety","Water Competency","Occupational Therapy","AquOTic","Drowning Prevention","INTERVENTIONAL","TREATMENT",[29],"NA",{"count":31,"type":32},108,"ESTIMATED",[34],{"type":14,"name":24,"description":35,"armGroupLabels":36},"AquOTic is an evidence-based, occupational therapy-led intervention designed to enhance water competency and swim safety skills in children on the autism spectrum. The 10-week program consists of weekly 60-minute group sessions, each including six children paired in a 1:1 ratio with an interventionist. Sessions follow a structured routine involving six rotating stations, targeting various swim and safety skills, with the flexibility for individualized support by the interventionist.",[37,38],"AquOTic with Community Interventionists","AquOTic with Professional Student Interventionist",[40],{"measure":41,"description":42,"timeFrame":43},"Water Orientation Test-Alyn (WOTA) 2","The WOTA2 measures a child's mental adaptation, adjustment to the pool, postural balance, and the ability to move and change position in the water, based on the Halliwick concept. WOTA2 assesses 27 swim skills scored on a 0-3 scale with a minimal detectable change score of 11.5. Higher scores indicate better skills. WOTA2 has high test-retest reliability (ICC=.97) and is validated for children with autism-like characteristics.","At baseline, immediately post-AquOTic, 6 months after termination of AquOTic, and 12 months after termination of AquOTic",[45,48,51],{"measure":46,"description":47,"timeFrame":43},"Water Orientation Test-Alyn (WOTA) 1","WOTA1 measures a child's mental adaptation, adjustment to the pool, postural balance, and the ability to move and change position in the water, based on the Halliwick concept. WOTA1 assesses 13 swim skills on a 1-4 scale with a minimal detectable change score of 4.5.",{"measure":49,"description":50,"timeFrame":43},"Water Competency Checklist (WCC)","WCC was developed by the AquOTic team and incorporates additional skills not on the WOTA that are considered necessary for water competence. These include jumping in and resurfacing, treading water, and turning around in the water. This checklist is a compilation of items from other swim checklists such as those used by the American Red Cross and clinical trials of swim interventions in autism",{"measure":52,"description":53,"timeFrame":43},"Canadian Occupational Performance Measure (COPM)","COPM is an individualized standardized outcome measure sensitive to change in performance over time. The COPM has been adapted for use in pediatric clinical trials for caregivers of children with disabilities. This measure will be administered by an occupational therapist via a semi-structured interview in which caregivers will identify 3-5 functional goals related to swim performance and water safety. Caregivers will rate how well their child performed each goal (COPM - Performance), and how satisfied they are with their child's performance (COPM - Satisfaction). The same caregiver will be interviewed at pre- and post-test assessments for the AquOTic program. A change of 2 or more points in each scale of the COPM is considered a minimum clinically important difference (MCID). The adapted COPM has high internal consistency (.86 - .88) with content and construct validity.","ALL","5 Years","9 Years",{"inclusion":58,"exclusion":64,"raw_text":73},[59,60,61,62,63],"Educational or medical diagnosis of autism","Age between 5 - 9 years","Having vision and hearing within normal limits with or without corrective modifications","Aged 18 or over","Demonstrate swim proficiency, as defined by the ability to tread water for 1 minute and move the body through the water without flotation for 25 yards",[65,66,67,68,69,70,71,72],"Children who demonstrate swim proficiency, as defined by the ability to tread water for 1 minute or move the body through the water without flotation","Open wounds or infectious skin diseases","Allergy to chlorine","Severe co-occurring motor impairments or neurological conditions such as uncontrolled seizures, Rett's or Angelman's syndrome","The family is unable to commit to the sessions or evaluations","Open wounds or infectious diseases","Failed background check","Unable to commit to Basic Swim Instructor and AquOTic training (\\~40 hours) and 10 AquOTic sessions (20 hours)","Children Participants (n=108)\n\nInclusion Criteria\n\n* Educational or medical diagnosis of autism\n* Age between 5 - 9 years\n* Having vision and hearing within normal limits with or without corrective modifications\n\nExclusion Criteria\n\n* Children who demonstrate swim proficiency, as defined by the ability to tread water for 1 minute or move the body through the water without flotation\n* Open wounds or infectious skin diseases\n* Allergy to chlorine\n* Severe co-occurring motor impairments or neurological conditions such as uncontrolled seizures, Rett's or Angelman's syndrome\n* The family is unable to commit to the sessions or evaluations\n\nInterventionists (n=64)\n\nInclusion Criteria\n\n* Aged 18 or over\n* Demonstrate swim proficiency, as defined by the ability to tread water for 1 minute and move the body through the water without flotation for 25 yards\n\nExclusion Criteria\n\n* Open wounds or infectious diseases\n* Failed background check\n* Unable to commit to Basic Swim Instructor and AquOTic training (\\~40 hours) and 10 AquOTic sessions (20 hours)",[75],"CHILD",[77],{"facility":78,"status":8,"city":79,"state":80,"zip":81,"country":82,"contacts":83,"geoPoint":92},"The Ohio State University","Columbus","Ohio","43210","United States",[84,89],{"name":85,"role":86,"phone":87,"email":88},"Erika Kemp, OTD","CONTACT","(608) 335 - 9230","erika.kemp@osumc.edu",{"name":90,"role":91},"Jewel Crasta, PhD","PRINCIPAL_INVESTIGATOR",{"lat":93,"lon":94},39.96118,-82.99879,[96,99],{"name":90,"role":86,"phone":97,"email":98},"(970) 682 - 8031","jewel.crasta@osumc.edu",{"name":85,"role":86,"phone":87,"email":88},[],[102,106],{"pmid":103,"type":104,"citation":105},"39435387","RESULT","Kemp E, Nikahd M, Howard M, Darragh A, Crasta JE. Improving water competency among children on the autism spectrum: the AquOTic randomized controlled trial. Front Pediatr. 2024 Oct 7;12:1473328. doi: 10.3389\u002Ffped.2024.1473328. eCollection 2024.",{"pmid":107,"type":108,"citation":109},"42552003","DERIVED","Kemp E, Juckett L, Sansone IO, Walton KM, Palettas M, Carson TB, Crasta JE. AquOTic: protocol for a type 1 hybrid effectiveness-implementation trial of an occupational therapy-based water competency intervention for children on the autism spectrum. BMJ Open. 2026 Aug 4;16(8):e117908. doi: 10.1136\u002Fbmjopen-2026-117908.",[],{"nct_id":4,"conditions":112,"biomarkers":114},[113],"Autism Spectrum Disorder",[],{"nct_id":4,"found":116,"summary":117,"prompt_version":127},true,{"design":118,"status":119,"heading":120,"summary":121,"follow_up":122,"word_count":123,"commitments":124,"compensation":125,"drugs_mentioned":126},"This interventional study plans to enroll 108 children. It is evaluating the AquOTic program.","completed","Water Competency Intervention in Autism (AquOTic)","This study is testing a program called AquOTic, which is an occupational therapy-led program designed to improve water safety and swimming skills for children with autism spectrum disorders. The program involves 10 weekly, 60-minute group sessions where children work one-on-one with an interventionist. Researchers want to see how well AquOTic helps children learn these skills. They will measure water competency using a test called WOTA-Alyn 2. The study is looking for 108 children, aged 5 to 9 years old, who have an autism diagnosis and normal vision and hearing. Children who are already proficient swimmers cannot participate. The current status of the study is unclear.","Participants will be followed for 12 months after the AquOTic program ends.",105,"Participants will attend 10 weekly 60-minute group sessions. Water competency will be measured at the start, immediately after the program, and then 6 and 12 months later.","Not stated in the trial record.",[24],"v2"]